Comprehensive Guide to Bioavailability and Bioequivalence Studies - Couverture souple

Chaki, Imran; Pujara, Naisarg; Sonak, Devyani

Couverture souple

ISBN 10 : 6630311906 ISBN 13 : 9786630311907

Editeur : LAP Lambert Academic Publishing, 2026

Synopsis

This book provides a comprehensive and practical guide to the scientific and regulatory principles governing bioavailability (BA) and bioequivalence (BE) studies in Brazil. Recognized as essential components of pharmaceutical development, BA/BE studies support the approval of generic, similar, and innovative medicines by demonstrating comparable therapeutic performance, ensuring product quality, patient safety, and clinical efficacy. The book consolidates ANVISA's extensive regulatory framework, including recent updates such as RDC No. 742/2022 and RDC No. 941/2024, into a single, accessible reference. Beyond summarizing regulations, it explains their scientific basis, practical application, and regulatory significance. Covering the complete lifecycle of BA/BE studies-from pharmacokinetic fundamentals, study design, volunteer management, ethical considerations, pharmaceutical equivalence, and bioanalytical method validation to statistical analysis, inspection readiness, and regulatory submission-this resource bridges theory and practice.

Détails de l'édition

• Éditeur: LAP Lambert Academic Publishing
• Date d'édition: 2026
• Langue: anglais
• ISBN 10: 6630311906
• ISBN 13: 9786630311907
• Reliure: Paperback
• Nombre de pages: 196
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible